Adrenocortical carcinoma · NCT06041516
A First-in-Human Phase I Trial With Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors, Carcinomas and Malignant Peripheral Nerve Sheath Tumors
- Status
- RECRUITING (ClinicalTrials.gov)
- Phase
- PHASE1
- Sponsor
- National Cancer Institute (NCI)
- Registry records
- CTGOV NCT06041516 (RECRUITING)Registry last updated 2026-11-02
Eligibility, line by line
| Verdict | In plain words (machine summary) | Registry text, verbatim | If unmet |
|---|---|---|---|
| inclusion inclusion · condition · confidence 0.97 | Participants must have histologically or cytologically confirmed neuroendocrine neoplasms or malignant adrenocortical carcinoma (ACC) or malignant peripheral nerve sheath tumors (MPNST). | "Participants must have histologically or cytologically confirmed neuroendocrine neoplasms or malignant adrenocortical carcinoma (ACC) or malignant peripheral nerve sheath tumors (MPNST)." | |
| inclusion inclusion · stage extent · confidence 0.96 | Locally advanced, unresectable or metastatic disease (as confirmed by a radiological evaluation) | "Locally advanced, unresectable or metastatic disease (as confirmed by a radiological evaluation)" | |
| inclusion inclusion · lesion burden · confidence 0.98 | Participants must have measurable disease per RECIST 1.1. | "Participants must have measurable disease per RECIST 1.1." | |
| inclusion inclusion · prior therapy · confidence 0.80 | Participants must have received prior standard of care treatment and be refractory to or intolerant to standard of care therapy(s). | "Participants must have received prior standard of care treatment and be refractory to or intolerant to standard of care therapy(s)." | |
| inclusion inclusion · prior therapy · confidence 0.30 | Patients with MPNST who have refused cytotoxic chemotherapy or for whom treatment on this protocol prior to receiving cytotoxic chemotherapy is felt to be in the best interest of the patient will also be eligible. | "Patients with MPNST who have refused cytotoxic chemotherapy" | |
| inclusion inclusion · age sex · confidence 0.98 | Age \>= 18 years. | "Age \>= 18 years." | |
| inclusion inclusion · performance status · confidence 0.98 | ECOG performance status \<= 2. | "ECOG performance status \<= 2." | |
| inclusion inclusion · lab value · confidence 0.98 | Leukocytes \>= 3,000/microliter | "Leukocytes \>= 3,000/microliter" | |
| inclusion inclusion · lab value · confidence 0.98 | Absolute neutrophil count (ANC) \>= 1,200/microliter | "Absolute neutrophil count (ANC) \>= 1,200/microliter" | |
| inclusion inclusion · washout · confidence 0.30 | ANC measured off growth factors for 72 hours prior to treatment initiation | "off-growth factors for 72 hours prior to treatment initiation" | |
| inclusion inclusion · lab value · confidence 0.98 | Hemoglobin (Hgb) \>= 9 g/dL | "Hemoglobin (Hgb) \>= 9 g/dL" | |
| inclusion inclusion · washout · confidence 0.30 | No blood transfusion within 2 weeks prior to treatment initiation | "no blood transfusion within 2 weeks prior to treatment initiation" | |
| inclusion inclusion · lab value · confidence 0.98 | Platelets \>= 100,000/microliter | "Platelets \>= 100,000/microliter" | |
| inclusion inclusion · washout · confidence 0.30 | No platelet transfusion within 1 week. | "no platelet transfusion within 1 week" | |
| inclusion inclusion · organ function · confidence 0.97 | Creatinine clearance (CrCl) \>= 50 mL/min/1.73 m\^2 | "Creatinine clearance (CrCl) \>= 50 mL/min" | |
| inclusion inclusion · organ function · confidence 0.96 | Total bilirubin \<= 1.5 x ULN | "Total bilirubin \<= 1.5 x ULN" | |
| inclusion inclusion · organ function · confidence 0.95 | In participants with known or suspected Gilbert's syndrome, total bilirubin \<= 3.0 x ULN | "in participants with known or suspected Gilbert's syndrome, total bilirubin \<= 3.0 x ULN" | |
| inclusion inclusion · organ function · confidence 0.95 | Alanine aminotransferase (ALT) \<= 2.5 x ULN | "Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 2.5 x ULN" | |
| inclusion inclusion · organ function · confidence 0.95 | Aspartate aminotransferase (AST) \<= 2.5 x ULN | "Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 2.5 x ULN" | |
| inclusion inclusion · organ function · confidence 0.93 | If liver metastases are present, ALT and AST must be \<= 5 x ULN | "unless liver metastases are present, then values must be" | |
| inclusion inclusion · comorbidity · confidence 0.30 | Participants serologically positive for hepatitis C virus (HCV) must have an undetectable HCV viral load. | "Participants serologically positive for hepatitis C virus (HCV) must have an undetectable HCV viral load." | |
| inclusion inclusion · comorbidity · confidence 0.30 | Participants serologically positive for Hepatitis B (HBV) core antibody or surface antigen must be on adequate anti-viral therapy and Hepatitis B Viral DNA load must be <2000 IU/mL. | "Participants serologically positive for Hepatitis B (HBV) core antibody or surface antigen must be on adequate anti-viral therapy" | |
| inclusion inclusion · comorbidity · confidence 0.30 | Participants serologically positive for HIV must be on stable antiretroviral therapy for at least 4 weeks before treatment initiation, have no reported opportunistic infections or Castleman s disease within 12 months, have undetectable viral load by PCR and CD4 count >= 200 cells per cubic millimeter. | "Participants serologically positive for human immunodeficiency virus (HIV) must be on stable antiretroviral therapy for at least 4 weeks before treatment initiation" | |
| inclusion inclusion · washout · confidence 0.30 | Participants with brain metastasis are eligible if at least 4 weeks status post radiotherapy or surgery before treatment initiation | "Participants with brain metastasis are eligible if at least 4 weeks status post radiotherapy or surgery before treatment initiation" | |
| inclusion inclusion · condition · confidence 0.90 | Brain metastasis participants must have no evidence of progression or associated symptoms. | "with no evidence of progression or associated symptoms" | |
| inclusion inclusion · pregnancy contraception · confidence 0.30 | Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception for the duration of study treatment and up to 9.5 months after the last dose of ADCT-701. | "Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception" | |
| inclusion inclusion · pregnancy contraception · confidence 0.30 | Individuals who can father children must agree to use an effective method of contraception at study entry and up to 6.5 months after the last dose of the ADCT-701. | "Individuals who can father children must agree to use an effective method of contraception" | |
| inclusion inclusion · pregnancy contraception · confidence 0.30 | Nursing participants must be willing to discontinue nursing from study treatment initiation through 6.5 months after study treatment discontinuation. | "Nursing participants must be willing to discontinue nursing" | |
| inclusion inclusion · consent · confidence 0.30 | Participants or legally authorized representative (LAR) must be able to understand and be willing to sign a written informed consent document. | "Participants or legally authorized representative (LAR) must be able to understand and be willing to sign a written informed consent document." | |
| exclusion exclusion · washout · confidence 0.95 | Major surgery, prior treatment with chemotherapy, hormonal therapy, immunotherapy, treatment with an investigational agent, and/or radiation therapy within 4 weeks or 5 half-lives, whichever is shorter, prior to treatment initiation. | "within 4 weeks or 5 half-lives, whichever is shorter, prior to treatment initiation" | |
| exclusion exclusion · washout · confidence 0.95 | Participants taking any herbal supplements within 14 days prior to treatment initiation. | "Participants taking any herbal supplements within 14 days prior to treatment initiation." | |
| exclusion exclusion · comorbidity · confidence 0.95 | Participants who have wound dehiscence from prior surgeries. | "Participants who have wound dehiscence from prior surgeries." | |
| exclusion exclusion · comorbidity · confidence 0.95 | Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or any serosal effusion that requires drainage or is associated with shortness of breath) at screening. | "Clinically significant third space fluid accumulation" | |
| exclusion exclusion · comorbidity · confidence 0.96 | Active infection requiring systemic antibiotic therapy at screening. | "Active infection requiring systemic antibiotic therapy at screening." | |
| exclusion exclusion · comorbidity · confidence 0.93 | Active bleeding diathesis or therapeutic anticoagulation with an oral vitamin K antagonist with target INR > 2 at screening. | "Active bleeding diathesis or therapeutic anticoagulation with an oral vitamin K antagonist" | |
| exclusion exclusion · comorbidity · confidence 0.95 | History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug. | "History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug." | |
| exclusion exclusion · comorbidity · confidence 0.93 | An active autoimmune disease (with exceptions for mild autoimmune disorders not requiring immunosuppressive treatment). | "An active autoimmune disease." | |
| exclusion exclusion · comorbidity · confidence 0.96 | Congenital long QT syndrome | "Congenital long QT syndrome" | |
| exclusion exclusion · organ function · confidence 0.93 | Corrected QTcF interval of >=480 ms at screening (unless secondary to the pacemaker or bundle branch block). | "unless secondary to the pacemaker or bundle branch block" | |
| exclusion exclusion · comorbidity · confidence 0.95 | Active second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that does not require current anticancer treatment per standard of care. | "Active second primary malignancy other than non-melanoma skin cancers" | |
| exclusion exclusion · washout · confidence 0.96 | Live vaccine administration within 30 days prior to treatment initiation. | "Live vaccine administration within 30 days prior to treatment initiation." | |
| exclusion exclusion · pregnancy contraception · confidence 0.95 | Pregnant individuals (confirmed by Beta-HCG serum or urine pregnancy test) performed at screening. | "Pregnant individuals (confirmed by Beta-Human Chorionic Gonadotropin" | |
| exclusion exclusion · comorbidity · confidence 0.95 | Uncontrolled intercurrent illness that would limit compliance with study requirements. | "Uncontrolled intercurrent illness that would limit compliance with study requirements." |
Criteria extracted by claude-sonnet-5-5; 0 extracted quotes rejected for not matching the registry text.
Full eligibility text as the registry publishes it
* INCLUSION CRITERIA: * Participants must have histologically or cytologically confirmed neuroendocrine neoplasms or malignant adrenocortical carcinoma (ACC) or malignant peripheral nerve sheath tumors (MPNST). * Locally advanced, unresectable or metastatic disease (as confirmed by a radiological evaluation) * Participants must have measurable disease per RECIST 1.1. * Participants must have received prior standard of care treatment and be refractory to or intolerant to standard of care therapy(s). Note: Patients with MPNST who have refused cytotoxic chemotherapy or for whom treatment on this protocol prior to receiving cytotoxic chemotherapy is felt to be in the best interest for the patient by the local investigator and treating investigator will also be eligible. * Age \>= 18 years. * ECOG performance status \<= 2. * Adequate hematologic function as follows: * Leukocytes \>= 3,000/microliter * Absolute neutrophil count (ANC) \>= 1,200/microliter (off-growth factors for 72 hours prior to treatment initiation) * Hemoglobin (Hgb) \>= 9 g/dL with no blood transfusion within 2 weeks prior to treatment initiation * Platelets \>= 100,000/microliter with no platelet transfusion within 1 week. * Adequate renal and hepatic function as follows: * Creatinine clearance (CrCl) \>= 50 mL/min/1.73 m\^2 (calculated CrCl (Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or calculated eGFR provided by a laboratory)) * Total bilirubin \<= 1.5 x ULN OR in participants with known or suspected Gilbert's syndrome, total bilirubin \<= 3.0 x ULN * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 2.5 x ULN, (unless liver metastases are present, then values must be \<= 5 x ULN). * Participants serologically positive for hepatitis C virus (HCV) must have an undetectable HCV viral load. * Participants serologically positive for Hepatitis B (HBV) core antibody or surface antigen must be on adequate anti-viral therapy and Hepatitis B Viral deoxyribonucleic acid (DNA) load must be \<2000 IU/mL. * Participants serologically positive for human immunodeficiency virus (HIV) must be on stable antiretroviral therapy for at least 4 weeks before treatment initiation, have no reported opportunistic infections or Castleman s disease within 12 months prior to treatment initiation, have a viral load that is undetectable by quantitative polymerase chain reaction (PCR) and CD4 count \>= 200 cells per cubic millimeter. * Participants with brain metastasis are eligible if at least 4 weeks status post radiotherapy or surgery before treatment initiation with no evidence of progression or associated symptoms. * Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization) for the duration of the study treatment and up to 9.5 months after the last dose of the ADCT-701 (restriction period). Individuals who can father children must agree to use an effective method of contraception (barrier, surgical sterilization) at study entry and up to 6.5 months after the last dose of the ADCT-701. * Nursing participants must be willing to discontinue nursing from study treatment initiation through 6.5 months after study treatment discontinuation. * Participants or legally authorized representative (LAR) must be able to understand and be willing to sign a written informed consent document. EXCLUSION CRITERIA: * Major surgery, prior treatment with chemotherapy, hormonal therapy, immunotherapy, treatment with an investigational agent, and/or radiation therapy within 4 weeks or 5 half-lives, whichever is shorter, prior to treatment initiation. * Participants taking any herbal supplements within 14 days prior to treatment initiation. * Participants who have wound dehiscence from prior surgeries. * Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or any serosal effusion that is either requires drainage or is associated with shortness of breath) at screening. * Active infection requiring systemic antibiotic therapy at screening. * Active bleeding diathesis or therapeutic anticoagulation with an oral vitamin K antagonist with target international normalized ratio (INR) \> 2 at screening. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug. * An active autoimmune disease. Note: Participants with type 1 diabetes, eczema, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease, adrenal insufficiency on systemic oral corticosteroid therapy (\<= the equivalent of prednisone 10 mg/day), or other mild autoimmune disorders (Type 1 diabetes, eczema, vitiligo, alopecia, rheumatoid arthritis, psoriasis, systemic lupus erythematosus, adrenal insufficiency due to Addison's disease, hypothyroidisms due to Hashimoto's thyroiditis, hyperthyroidisms due to Graves disease, Sjogren s syndrome, celiac disease, pernicious anemia) not requiring immunosuppressive treatment are eligible. * Congenital long QT syndrome, or a corrected QTcF interval of \>=480 ms, at screening (unless secondary to the pacemaker or bundle branch block). * Active second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that does not require current anticancer treatment per standard of care. * Live vaccine administration within 30 days prior to treatment initiation. * Pregnant individuals (confirmed by Beta-Human Chorionic Gonadotropin \[Beta-HCG\] serum or urine pregnancy test) performed at screening. * Uncontrolled intercurrent illness that would limit compliance with study requirements.
Routes in: how this trial is reached and paid for
NIH Clinical Center: care at no cost, travel supported
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For non-US residents NIH provides airfare from the nearest US point of entry and a nightly hotel allowance. That makes Bethesda cheaper to reach than most US hospitals despite the distance. Ask the study contact what the current travel policy covers before booking anything.
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Care 0; transatlantic flight at your own cost, then supported
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- National Institutes of Health Clinical Center, Bethesda